Recombinant therapeutic proteins are commonly expressed in cell expression systems, e.g., mammalian cell expression systems. In 2014, the total number of market approved biopharmaceuticals was 212, and 56% of the therapeutic products approved for market by the FDA are produced in mammalian cell lines. However, the high cost associated with production contributes to increasing global health costs.
Moreover, next generation protein biologics (NGBs) such as next generation fusion proteins, multimeric glycoproteins, or next generation antibodies often have a complex and/or non-natural structure and are proving more difficult to express than molecules such as monoclonal antibodies. Current host cell lines have not evolved pathways for the efficient synthesis and secretion of NGBs, resulting in significantly reduced growth, low productivity and often resulting in products with poor product quality attributes. Thus, these NGBs are considered difficult to express, in which the productivity and product quality do not meet clinical and market needs.
Accordingly, there is an increasing need to develop and produce recombinant biotherapeutics rapidly, efficiently, and cost-effectively while maintaining final product quality.